IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TENNESSEE
`GREENEVILLE DIVISION
`
`
`DENTSPLY INTERNATIONAL INC.
`and TULSA DENTAL PRODUCTS LLC
`d/b/a TULSA DENTAL SPECIALTIES
`
`
`Plaintiffs,
`
`
`v.
`
`
`US ENDODONTICS, LLC
`
`
`Defendant.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Civil Action No. 2:14-cv-00196
`Judge J. Ronnie Greer
`Magistrate Judge Dennis H. Inman
`
`HIGHLY CONFIDENTIAL
`
`
`
`
`
`EXPERT REPORT OF ROBERT SINCLAIR, PH.D.
`
`I.
`
`INTRODUCTION
`
`1.
`
`I, Robert Sinclair, Ph.D., have been retained by Plaintiffs Dentsply International
`
`Inc. and Tulsa Dental Products LLC d/b/a Tulsa Dental Specialties (collectively “Plaintiffs” or
`
`“Dentsply”) to serve as an expert witness in the above-captioned matter. I expect to testify
`
`regarding the matters discussed in this report as well as any supplemental report that I may later
`
`submit and to respond to any testimony that Defendant US Endodontics, LLC (“US Endo”) may
`
`offer at the preliminary injunction hearing.
`
`II.
`
`BACKGROUND AND QUALIFICATIONS
`
`2.
`
`I hold a B.A. in Materials Science (1968) and a Ph.D. in Materials Science
`
`(1972), both from Cambridge University. After receiving my Ph.D., I worked from 1973-1977 as
`
`a Postdoctoral Research Engineer at the University of California, Berkeley.
`
`3.
`
`Since 1977, I have been employed at Stanford University in Stanford, California,
`
`where I have successively served as Assistant Professor in Materials Science and Engineering
`
`1 of 7
`
`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
`
`
`FOR THE EASTERN DISTRICT OF TENNESSEE
`GREENEVILLE DIVISION
`
`
`DENTSPLY INTERNATIONAL INC.
`and TULSA DENTAL PRODUCTS LLC
`d/b/a TULSA DENTAL SPECIALTIES
`
`
`Plaintiffs,
`
`
`v.
`
`
`US ENDODONTICS, LLC
`
`
`Defendant.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Civil Action No. 2:14-cv-00196
`Judge J. Ronnie Greer
`Magistrate Judge Dennis H. Inman
`
`HIGHLY CONFIDENTIAL
`
`
`
`
`
`EXPERT REPORT OF ROBERT SINCLAIR, PH.D.
`
`I.
`
`INTRODUCTION
`
`1.
`
`I, Robert Sinclair, Ph.D., have been retained by Plaintiffs Dentsply International
`
`Inc. and Tulsa Dental Products LLC d/b/a Tulsa Dental Specialties (collectively “Plaintiffs” or
`
`“Dentsply”) to serve as an expert witness in the above-captioned matter. I expect to testify
`
`regarding the matters discussed in this report as well as any supplemental report that I may later
`
`submit and to respond to any testimony that Defendant US Endodontics, LLC (“US Endo”) may
`
`offer at the preliminary injunction hearing.
`
`II.
`
`BACKGROUND AND QUALIFICATIONS
`
`2.
`
`I hold a B.A. in Materials Science (1968) and a Ph.D. in Materials Science
`
`(1972), both from Cambridge University. After receiving my Ph.D., I worked from 1973-1977 as
`
`a Postdoctoral Research Engineer at the University of California, Berkeley.
`
`3.
`
`Since 1977, I have been employed at Stanford University in Stanford, California,
`
`where I have successively served as Assistant Professor in Materials Science and Engineering
`
`1 of 7
`
`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
`
`
`
`37.
`
`The property imputed to the instrument as a result of step (b) in the ‘773 patent is:
`
`“wherein the heat-treated shank has an angle greater than 10 degrees of permanent deformation
`
`after torque at 45º flexion when tested in accordance with ISO Standard 3630-1.”
`
`C.
`
`38.
`
`Independent Testing of the EdgeFiles
`
`I have reviewed and am familiar with the results of the thermal testing (DSC)
`
`conducted on each of the EdgeFiles by Veritas.
`
`39.
`
`Samples of EdgeFiles were provided to Veritas as unopened packages of 3 or 6
`
`files in the form in which they are commercially available. Prior to testing, each file was cut
`
`from the tip of the EdgeFiles for each specimen into small segments using a diamond saw.
`
`Segments of sample material of approximately 5 mm were found to weigh between 5-15
`
`milligrams.
`
`40.
`
`The DSC testing performed by Veritas utilized a PerkinElmer DSC6000 with an
`
`Intracooler 2 instrument. The instrument was calibrated to the manufacturer’s specifications
`
`using indium and zinc standard supplied by the manufacturer. Each sample was placed in the
`
`DSC instrument, and that the instrument was cooled to -65 ºC for 1 minute before increasing the
`
`temperature at 10 ºC per minute until reaching 100 ºC. Samples of each EdgeFile type (X1, X3,
`
`X5, X7, and XR) were tested in triplicate.
`
`41.
`
`The DSC curves showing the results of the thermal analysis of the EdgeFiles were
`
`provided. The table below provides a key to the samples tested and the results. The procedure in
`
`the ASTM standard was utilized to calculate the As, Af, Ms, and Mf data points.
`
`2 of 7
`
`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
`
`
`
`Product
`
`Size Length
`
`
`
`
`
`
`
`EdgeFile X1 25.06 25 mm
`
`
`
`
`
`
`
`
`
`
`
`
`
`EdgeFile X3
`
`N2
`
`25 mm
`
`
`
`
`
`
`
`
`
`
`
`
`
`R-Phase
`start
`temp
`(Rs)
`
`martensite
`start temp
`(Ms)
`
`R-Phase
`finish
`temp
`(Rf)3
`
`martensite
`finish
`temp (Mf)4
`
`28 °C
`
`28 °C
`
`27 °C
`
`29 °C
`
`29 °C
`
`28 °C
`
`28 °C
`
`-17 °C
`
`-18 °C
`
`-18 °C
`
`-37 °C
`
`-37 °C
`
`-38 °C
`
`-20 °C
`
`-19 °C
`
`21 °C
`
`22 °C
`
`21 °C
`
`21 °C
`
`19 °C
`
`20 °C
`
`22 °C
`
`22 °C
`
`-35 °C
`
`-36 °C
`
`-36 °C
`
`-51 °C
`
`-58 °C
`
`-51 °C
`
`-39 °C
`
`-39 °C
`
`DSC
`Curve2
`22714011
`Sample 1
`22714011
`Sample 2
`22714011
`Sample 3
`20614010
`Sample 1
`20614010
`Sample 2
`20614010
`Sample 3
`81913031
`Sample 1
`81913031
`Sample 2
`81913031
`Sample 3
`31014023
`Sample 1
`31014023
`Sample 2
`31014023
`Sample 3
`22714092
`Sample 1
`22714092
`Sample 2
`22714092
`Sample 3
`
`EdgeFile X5 40.04 25 mm
`
`
`
`
`
`
`
`
`
`
`
`
`
`EdgeFile X7 35.06 25 mm
`
`
`
`
`
`
`
`
`
`
`
`
`
`EdgeFile XR
`
`R4
`
`23 mm
`
`
`
`
`
`
`
`
`
`27 °C
`
`27 °C
`
`29 °C
`
`28 °C
`
`29 °C
`
`
`
`
`
`
`
`-19 °C
`
`-19 °C
`
`-19 °C
`
`-20 °C
`
`3 °C
`
`0 °C
`
`1 °C
`
`22 °C
`
`23 °C
`
`22 °C
`
`22 °C
`
`
`
`
`
`
`
`-38 °C
`
`-37 °C
`
`-37 °C
`
`-36 °C
`
`-38 °C
`
`-45 °C
`
`-42 °C
`
`42.
`
`Veritas also provided a supplemental analysis in which one DCS curve from each
`
`file tested was reproduced with the austenite finish temperature determination included. The
`
`2 The number corresponds to the Lot number on the packaging.
`3 This value was calculated by hand.
`4 This value was calculated by hand.
`
`3 of 7
`
`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
`
`
`
`table below provides a key to the supplemental DSC curves. The procedure in the ASTM
`
`standard was utilized to calculate the As, Af, Ms, and Mf data points.
`
`Product
`
`Size
`
`Length
`
`Lot
`
`EdgeFile X1
`
`25.06
`
`EdgeFile X3
`
`N2
`
`EdgeFile X5
`
`EdgeFile X7
`
`40.04
`
`35.06
`
`EdgeFile XR
`
`R4
`
`
`
`25 mm
`
`25 mm
`
`25 mm
`
`25 mm
`
`23 mm
`
`22714011
`
`20614010
`
`81913031
`
`31014023
`
`22714092
`
`DSC Curve
`22714011
`Sample 1
`20614010
`Sample 3
`81913031
`Sample 2
`31014023
`Sample 3
`22714092
`Sample 1
`
`Austenite
`finish temp
`(Af)
`
`39 °C
`
`35 °C
`
`37 °C
`
`41 °C
`
`4 °C
`
`43.
`
`I have reviewed and am familiar with mechanical testing conducted on each of the
`
`EdgeFiles by Knight Mechanical. A report on the mechanical bend testing performed by Knight
`
`Mechanical in accordance with ISO Standard 3630-1 was provided. Samples of the EdgeFiles
`
`were provided to Knight Mechanical as unopened packages of 3 or 6 files in the form in which
`
`they are commercially available.
`
`44.
`
`A device was assembled in accordance with ISO Standard 3630-1 and a stiffness
`
`test was conducted in accordance with Section 7.5. After the stiffness test was completed, the
`
`files were measured for any angle of permanent deformation. The table below provides a key to
`
`the samples tested and the results.
`
`Size Length Sample
`Product
`
`
`X1_S1
`
`EdgeFile X1 25.06
`25 mm X1_S2
`
`
`
`X1_S3
`
`
`
`X3_S1
`EdgeFile X3 N2
`25 mm X3_S2
`
`Torque at 45°
`Angular
`Displacement
`(mN·m)
`3.60
`3.53
`3.35
`0.93
`0.91
`
`Post-testing Permanent
`Deformation Angle
`(degrees)
`23.75
`27.00
`27.33
`1.83
`3.58
`
`4 of 7
`
`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
`
`
`
`
`
`
`
`EdgeFile X5 40.04
`
`
`
`
`EdgeFile X7 35.06
`
`
`
`
`EdgeFile XR R4
`
`
`
`
`X3_S3
`
`X5_S1
`
`25 mm X5_S2
`
`X5_S3
`
`X7_S1
`25 mm X7_S2
`
`X7_S3
`
`XR_S1
`23 mm XR_S2
`
`XR_S3
`
`1.35
`5.46
`4.85
`4.98
`6.49
`7.43
`7.44
`3.76
`3.43
`4.24
`
`2.17
`13.50
`11.75
`19.83
`29.00
`29.08
`26.67
`1.00
`0.25
`0.42
`
`D.
`
`45.
`
`Defendant US Endo’s Heat Treatment Process
`
`In his August 1, 2014 declaration, Mr. Bobby Bennett states that US Endo
`
`receives fluted, nickel titanium endodontic files from a third-party supplier, and then heat-treats
`
`the files in an industrial oven for the manufacture of EdgeFiles X1, X35, X5, and X7. (Bennett
`
`Declaration signed August 1, 2014 at ¶¶ 7, 8, 12, 13).
`
`46.
`
`Documents produced by US Endo outline the processing steps for the heat
`
`treatment of the EdgeFiles in more detail. First, the oven is warmed to a “proprietary
`
`temperature.” See, e.g., USENDO0000006 (Sequence # 4); USENDO0000011 (Sequence # 7).
`
`Next, the files are loaded into a metal tubes (USENDO0000006 (Sequence # 5)), and the tubes
`
`are loaded into the oven. USENDO0000007 (Sequence # 6). The oven door is shut and the tubes
`
`containing the entire files are heated for a period of time, which is recorded on a corresponding
`
`product router document. USENDO0000007 (Sequence # 7-9). The date, tube number, and time
`
`log for each heat treatment is recorded in the US Endo Heat Treat Log. See USENDO0000129-
`
`USENDO0000179. The quantities of files that are heat-treated, as well as the time of the day in
`
`which the tubes containing the files are loaded into and taken out of the oven, are recorded on
`
`US Endo Product Router documents. See, e.g., USENDO0000201.
`
`5 Mr. Bennett states that there is one type of the X3 EdgeFile having a specific taper that is not
`heat-treated; however, he admits that other X3 EdgeFiles are heat-treated.
`
`5 of 7
`
`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
`
`
`
`E.
`
`Comparison of the EdgeFiles with Claim 1 of the ‘773 Patent
`
`Step 1: “providing”
`
`51.
`
`According to the declaration of Mr. Bobby Bennett of August 1, 2014, EdgeFiles
`
`X1, X5, and X7 are fluted, nickel titanium files that are heat-treated, whereas EdgeFile XR is a
`
`fluted, nickel-titanium file that is not treat-treated.
`
`52.
`
`As shown by the mechanical bend testing results, the EdgeFile XR does not
`
`demonstrate permanent deformation when subjected to the testing in standard ISO 3630-1. See
`
`supra at 54. In other words, when a bending force is applied to EdgeFile XR and subsequently
`
`released, the file will spring back straight rather than remain permanently deformed. Thus, the
`
`EdgeFile XR is superelastic. It follows that EdgeFiles X1, X5, and X7—which are fluted, nickel
`
`titanium files when received by US Endo—are also superelastic.
`
`53.
`
`Accordingly, it follows that US Endo’s process for manufacturing the EdgeFiles,
`
`or at least the EdgeFiles X1, X5, and X7, includes the first step in the ‘773 patent: “(a) providing
`
`an elongate shank having a cutting edge extending from a distal end of the shank along an axial
`
`length of the shank, comprising a superelastic nickel titanium alloy.” In other words, before heat
`
`treatment, the EdgeFiles have a cutting edge and comprise a superelastic nickel titanium alloy.
`
`Step 2: “heat-treating”
`
`54.
`
`The product packaging for Edge Endo’s EdgeFiles X1, X5 and X7 indicate that
`
`the products are “HEAT TREATED NiTi FILES.”
`
`55.
`
`The August 1, 2014 declaration submitted by Mr. Bobby Bennett states that the
`
`EdgeFiles are prepared by heat-treating nickel titanium files.
`
`56.
`
`The procedure outlined in the US Endo documents call for the following steps:
`
`load the files into tubes; load the tubes into the oven; and close the oven door. See
`
`6 of 7
`
`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
`
`
`
`7 of 7
`
`PGR2015-00019 - Ex. 1019
`US ENDODONTICS, LLC., Petitioner
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